Safety Study of AMG 557 in Subjects With Lupus Arthritis

Amgen20 enrolled

Overview

This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lupus Arthritis, Systemic Lupus Erythematosus

Interventions

AMG 557DRUG

AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.

Matching PlaceboDRUG

Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria * Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥ 6 at screening; * Other inclusion criteria may apply. Exclusion Criteria: * Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years * Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE * Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies * Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening * Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study * Other exclusion criteria may apply

Locations (13)

Research Site

Los Angeles, California, United States

Research Site

San Leandro, California, United States

Research Site

Danbury, Connecticut, United States

Outcomes

Primary Outcomes

Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557.

Time frame: 330 days, including a 21-day screening period

Lupus Arthritis Response Rate

Defined by: 1) achieving at least a 50% decrease in the combined tender and swollen joint count compared to baseline at Day 169; 2) achieving one letter improvement in the Musculoskeletal System BILAG at Day 169 compared to baseline; 3) reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 50% of baseline corticosteroid dose (Day 1 predose) or ≤ 7.5 mg/day, whichever is lower, from Day 85 to Day 169 in subjects not treated with immunosuppressants at baseline, or reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 7.5 mg/day from Day 85 to Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline

Time frame: Day 169

Secondary Outcomes

Proportion of subjects achieving a) one letter improvement; and b) 'C' or better score in the Musculoskeletal system from BILAG index at Day 169 compared to baseline, by treatment group.

Time frame: Day 169

Percentage change in the tender and swollen joint counts at Day 169 relative to baseline.

Time frame: Day 169

Proportion of subjects achieving reduction in and maintenance ≤ 7.5 mg/day of prednisone (or equivalent) from Day 85- Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline.

Time frame: Days 85-169

Proportion of subjects achieving reduction in and maintenance of prednisone (or its

Time frame: Days 85-169

Data from ClinicalTrials.gov

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